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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH070805 | U.S. NIH Grant/Contract | View source | |
| DSIR 83-ATAS |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of an online cognitive behavioral therapy intervention in improving sleep, mood, and cognitive functioning in people with insomnia.
Insomnia is a disorder that is characterized by a perception or complaint of inadequate or poor-quality sleep. Symptoms of insomnia include difficulty falling asleep, waking frequently during the night and having difficulty returning to sleep, waking too early in the morning, and unrefreshing sleep. Insomnia may also cause problems during the day, such as tiredness, difficulty concentrating, and irritability. Cognitive behavior therapy (CBT) has been found to have significant short- and long-term benefits for people with insomnia. Access to CBT for many people, however, is limited, due to the high cost of treatment and a lack of trained professionals in some locations. Delivering CBT via the internet could help make the treatment more widely available. This study will evaluate the effectiveness of an online CBT intervention in improving sleep, mood, and cognitive functioning in people with insomnia.
Participants in this open label study will be randomly assigned to receive the online CBT intervention either immediately or after a 4-month waiting period. Participants will use the online program for 1 to 2 hours per week for 8 weeks. Participants will keep track of their sleep patterns for the first and last 2 weeks of a 4-month period by keeping a daily diary and wearing a wrist watch device that monitors movement. All participants will report to the study site for baseline evaluations before beginning treatment and for final evaluations upon completing the program, about 4 months after study entry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive the online CBT intervention immediately and will use the online program for 8 weeks |
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| 2 | Active Comparator | Participants will receive the online CBT intervention after a 4-month waiting period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral treatment (CBT) delivered over the Internet | Behavioral | CBT delivered over the Internet for insomnia targets maladaptive behaviors and dysfunctional thoughts that perpetuate sleep problems. Treatment includes through educational, behavioral, and cognitive strategies. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency, total sleep time, total wake time, sleep-onset latency, wake after sleep onset, and early morning awakening | Measured at baseline and Months 3 and 9 | |
| Insomnia Severity Index | Measured at baseline and Months 3 and 9 | |
| Beliefs and attitudes about sleep as measured by the Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS 16) | Measured at baseline and Month 3 | |
| Sleep knowledge | Measured at baseline and Month 3 | |
| Fatigue as measured by the Multidimensional Fatigue Symptom Inventory (MFSI) | Measured at baseline and Month 3 | |
| Depression as measured by the Beck Depression Inventory 2 | Measured at baseline and Month 3 | |
| Anxiety as measured by the State-Trait Personality Inventory (STPI) | Measured at baseline and Month 3 | |
| Cognitive functioning as measured by the Headminder's Customized Research Tool (CRT) and Conner's Continuous Performance Test (CPT) | Measured at baseline and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-benefit measures (direct and indirect costs associated with insomnia) | Measured at baseline and Months 3 and 9 | |
| Quality of life as measured by the SF-12 Health Survey | Measured at baseline and Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee M. Ritterband, PhD | University of Virginia Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System, Behavioral Health and Technology | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33057694 | Derived | Shaffer KM, Finkelstein EA, Camacho F, Ingersoll KS, Thorndike F, Ritterband LM. Effects of an Internet-Based Cognitive Behavioral Therapy for Insomnia Program on Work Productivity: A Secondary Analysis. Ann Behav Med. 2021 Jun 2;55(6):592-599. doi: 10.1093/abm/kaaa085. | |
| 32511726 | Derived | Shaffer KM, Hedeker D, Morin CM, Ingersoll K, Thorndike F, Ritterband LM. Intraindividual variability in sleep schedule: effects of an internet-based cognitive-behavioral therapy for insomnia program and its relation with symptom remission. Sleep. 2020 Dec 14;43(12):zsaa115. doi: 10.1093/sleep/zsaa115. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Feedback regarding use of the internet intervention, including post-treatment ratings of treatment credibility, acceptability, effectiveness, satisfaction, and ease of use of the internet | Measured at Month 3 |
| 19581560 | Derived | Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009 Jul;66(7):692-8. doi: 10.1001/archgenpsychiatry.2009.66. |
| D001523 |
| Mental Disorders |